Vaccination order and Pain response in Newborns

Pain response in newborns to the order of injecting BCG and Hepatitis-B vaccines

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000426

Enrollment

Registered

2010-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BCG vaccine injection first followed by HepatitisB vaccine injection: 0.1 ml of BCG vaccine (TUBERVAC?) was administered intradermally at the convex aspect of the left shoulder using a

Eligibility

Inclusion criteria

Inclusion criteria: Randomized study of full term healthy newborns who received the routine dose of BCG and the Hepatitis-B vaccine in the vaccination room of Pediatric Department; KVG Medical College Hospital; Sullia.

Exclusion criteria

Exclusion criteria: We excluded sick newborns , 5 minute APGAR<7, low birth weight babies, and those who were discharged before the weekly vaccination day.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure was the neonatal pain. Pain assessment was done using the neonatal infant pain scale (NIPS).Timepoint: it was measured prior to the vaccine injections and during the vaccine injections.	—

Secondary

Measure	Time frame
10-cm visual analog scale (VAS)Timepoint: Obtained immediately after the first and second vaccine injections.	—

Countries

India

Contacts

Public ContactSR Ravikiran

ravisaralaya@gmail.com9480238528

Outcome results